Cleared Traditional

DELFIA SHBG KIT

K940449 · Wallac OY · Chemistry
Sep 1994
Decision
217d
Days
Class 1
Risk

About This 510(k) Submission

K940449 is an FDA 510(k) clearance for the DELFIA SHBG KIT, a Radioimmunoassay, Testosterones And Dihydrotestosterone (Class I — General Controls, product code CDZ), submitted by Wallac OY (Finland, FI). The FDA issued a Cleared decision on September 6, 1994, 217 days after receiving the submission on February 1, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1680.

Submission Details

510(k) Number K940449 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 1994
Decision Date September 06, 1994
Days to Decision 217 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CDZ — Radioimmunoassay, Testosterones And Dihydrotestosterone
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1680